DISSOLUTION TESTING (USP 1, 2, 5, 6)

Overview Group

Overview

Dissolution is a test used by the Pharmaceutical industry to characterize the dissolution properties of the active drug, the active drug's release and the dissolution from a dosage formulation. Dissolution testing is used to formulate the drug dosage form and to develop quality control specifications for its manufacturing process. In-vitro dissolution testing is a critical test that has to correlate with in-vivo clinical studies and which could require specific method developments. Dissolution testing is described in many pharmacopeias, in EP, USP chapters and FDA guidelines.

 

USP 1, 2, 5, 6

Tablets are classically tested according to the USP 2 paddle method. Swelling or floating dosage forms such as capsules are tested according to USP 1 basket method. USP 5 (paddle-over-disk) and USP 6 (rotating cylinder) are used for transdermal dosage forms.

Choose Your Automation Level

Defining the level of automation that best fits the product and throughput requirements can help to ensure reproducibility and standardization of your dissolution test. The sequence of individual process steps before (pre-run), during (dissolution run), and after (post-run) the dissolution test include:

 

Manual

When dissolution is performed manually, every process step before, during, and after the test is executed manually by the user. This is the most technician-dependent way of testing.

 

Semi-automated (Single System)

Semi-automated systems ensure that all sequential steps during the dissolution run are reproducibly executed without requiring user interaction until the post-run activity. A semi-automated single dissolution system will give the user the throughput of one dissolution bath, i.e. test 6 samples.

 

Semi-automated (Double System)

With a semi-automated double system all sequential steps during the dissolution run are reproducibly executed without requiring user interaction until the post-run activity. Compared to a single system, a double dissolution system will give the user the possibility to increase his throughput by using two dissolution baths, i.e. test 12 samples.

 

Fully automated (AT MD)

Fully automated systems automate the complete dissolution process – from preparation to cleaning. Several tests of the same or different products can be executed directly after each other – without requiring any user action. With the AT MD, the complete workflow is automated, allowing the batching of up to 8 unattended dissolution tests.

 

Fully automated (AT 70smart)

As with the AT MD, the AT 70smart fully automated dissolution system also automates the complete dissolution process – from preparation to cleaning. Several tests of the same or different products can be executed directly after each other – without requiring any user action. Compared to the AT MD, the AT 70smart provides higher throughput, allowing the batching of up to 15 unattended dissolution tests.

 

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